Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy (HiPPo)

Hilotherapy for Prevention of Chemotherapy-induced Peripheral Polyneuropathy - a Unicentric, Prospective-controlled, Randomized Clinical Trial for Comparison of Local Hilotherapy Vs. No Therapy to Prevent Peripheral Polyneuropathy During Taxan-based Chemotherapy Regimen

Prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by Taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.

Study Overview

• Status: Recruiting
• Conditions: Equipment and Supplies
• Intervention / Treatment: Device: Hilotherm ChemoCare

Detailed Description

In this trial, patients receiving Taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. The cooling will be provided by a machine called Hilotherm ChemoCare unit and will be administered constantly at a temperature of 15-17°C. Randomization will be 50:50.

if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy.

To assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen.

Quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelina Fink, Dr. med.; Phone Number: +4973150058688; Email: angelina.fink@uniklinik-ulm.de

Study Locations

• Germany
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89075
      • Recruiting
      • University Hospital of Ulm
      • Contact: Angelina Fink, Dr. med.; Phone Number: +4973150058688; Email: angelina.fink@uniklinik-ulm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written consent for participation in this trail
• Age ≥18 years
• Female
• Breast or genital cancer of the woman
• Planned application of a Taxan-based chemotherapy regimen (Paclitaxel, Nab-Paclitaxel, Docetaxel) independent of the therapy line
• Taxan- and Platin-naivity
• Sufficient knowledge of the German language to assure an adequat survey of patient's history

Exclusion Criteria:

• pre-existing peripheral polyneuropathy
• chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy
• Existence of one of the following diseases: Diabetes mellitus (of any type), neurological diseases that are involving peripheral nerve damage (e.g. Multiple Sclerosis, Amytrophic lateral sclerosis, Parkinson's disease), chronic pain syndrome, Cryoglobulinemia, cold hemagglutination, cold hives / cold contact hives, Raynaud's disease, significant peripheral artery disease,
• Lack of knowledge of German
• Males

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hilotherapy; Cooling of hands and feet during Taxan-based chemotherapy	Device: Hilotherm ChemoCare; Hilotherapy
No Intervention: No Cooling; No cooling of hands and feet during Taxan-based chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of peripheral polyneuropathy	The primary endpoint of this study is the comparison of the incidence of a peripheral polyneuropathy (clinical Total Neuropathy Score cTNS ≥ 11) in patients with gynecologic malignoma that are undergoing Taxan-based chemotherapy regimen with or without a preventive hilotherapy of hands and feet.	Up to one year after the end of chemotherapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the result of electrophysical examinations	Changes in the result of electrophysical examinations before and after chemotherapy.	From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Adverse effects of hilotherapy	Adverse effects of hilotherapy documented as any adverse event.	Up to one year after the end of chemotherapy.
Tolerance of chemotherapy	Tolerance of chemotherapy measured as the proportion of patient with dose reduction or premature end of chemotherapy.	From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.
Patient reported Quality of Life	Quality of Life of patients measured with the EORTC QLQ-C30 questionnaire	Up to one year after the end of chemotherapy.
Residual Symptoms of Chemotherapy-induced polyneuropathy	Comparison of the time of regression, cTNS score of persisting symptoms and amount of patients without residues after end of chemotherapy and follow-up between patients with and without preventive hilotherapy.	Up to one year after the end of chemotherapy.
Subjective extent of CIPN	Subjective extent of CIPN as measured with the EORTC QLQ-CIPN20 (quality of life questionnaire regarding chemotherapy-induced peripheral neuropathy with 20 questins) questionnaire. The qustionnaire consits of 20 items on 3 scales. The minimum is 0, the maximum is 100 points. The higher the score, the worse the CIPN.	Up to one year after the end of chemotherapy.
Acceptance of hilotherapy	Acceptance of hilotherapy measured as the amount of patients that have to stop local cold application during a session (up to 5 minutes) or terminate earlier or stop the treament completely for the rest of chemotherapy.	From the beginning to the end of chemotherapy, exact time frame depending on the chemotherapy regimen, assessed up to 30 weeks.

Collaborators and Investigators

• Sponsor: University of Ulm
• Collaborators: Hilotherm

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Chemo-induced Peripheral Polyneuropathy; Taxan; Hilotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies
• Other Study ID Numbers: HIPPO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No